Glaucoma / ocular hypertension Eye Diseases
Conditions
Interventions
The study is testing a new way of working in outpatient glaucoma clinics. The 'intervention' is an adaptation of the clinical appointments into two sessions separated by four weeks in which intraocula
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RQ1: CLINICAL OBSERVATIONS, SITUATED INTERVIEWS AND SURVEY Observations and Situated Interviews: 1. Aged 18 years or over 2. Attending an outpatient glaucoma clinic 3. Diagnosed with either glaucoma, ocular hypertension, normal tension glaucoma or pseudo-exfoliative glaucoma 4. Cognitively able to participate in the study 5. Able to speak English or have access to an interpreter. 6. Healthcare professionals will be eligible for inclusion if they are providing care to patients fitting the inclusion criteria within either of the primary research sites. Survey: 1. Glaucoma specialist lead or nominated individual in a Welsh health board aside from Cwm Taf University Health Board and Cardiff and Vale University Health Board. RQ2: SOP DEVELOPMENT AND FOCUS GROUPS ON STANDARD OPERATING PROCEDURE SOP Development: 1. From one of the following stakeholder groups: nurses, doctors, optometrists, orthoptists, pharmacists, and glaucoma patients. 2. Aged 18 years or over 3. Must be cognitively able to participate 4. Able to speak English. Focus Groups: 1. From one of the following stakeholder groups: glaucoma patient, lay carer of a glaucoma patient, doctor providing glaucoma care, pharmacist, optometrist, orthoptist, nurse providing glaucoma care, policy maker or NHS manager. 2. Aged 18 years or over 3. Must be cognitively able to participate 4. Able to speak English. RQ3: COHORT FEASIBILITY STUDY CMGC Cohort Feasibility Study: 1. Aged 18 years or over 2. Diagnosed with either primary open angle glaucoma, ocular hypertension, pseudo-exfoliative glaucoma, IOP equal to or greater than 21 mmHg, or normal tension glaucoma 3. Be on the point of being prescribed glaucoma eye drops. 4. Must be cognitively able to participate 5. Able to speak English or have access to an interpreter. CMGC Staff Training: 1. Healthcare professionals are required to be working in one of the two ophthalmic research sites as either a doctor, nurse, orthoptist or optometrist. RQ4: PATIENT / HEALTHCARE PROFESSIONAL INTERVIEWS AND OBSERVATION Patient Interviews: 1. Adult patients aged 18 years or over 2. Diagnosed with either glaucoma, ocular hypertension, normal tension glaucoma or pseudo-exfoliative glaucoma 3. Cognitively able to participate in the study 4. Have either i) never participated in CMGC and whom are eye drop naïve, or ii) never participated in CMGC and who are established eye drop users, or iii) participated in CMGC and are up to 4 months post-CMGC. Healthcare Professional Interviews: 1. Healthcare professional or member of the management team involved in the operation of the CMGC study. Observation: Either: 1. Glaucoma patient receiving the CMGC intervention (aged 18 years or over) OR 2. Healthcare professional or member of the clinical team involved in the operation of the CMGC study
Exclusion criteria
Exclusion criteria: RQ3: COHORT FEASIBILITY STUDY CMGC Cohort Feasibility Study: 1. Ocular surgery in the last three months 2. Having a form of acute glaucoma 3. Already being prescribed and taking eye drops 4. Any other condition that may affect drop efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RQ3: 3.1 The number of participants recruited 3.2 The proportion recruited from those approached 3.3 The time (in months) from clinics being open to recruit to stopping recruiting 3.4 The proportion of participants who receive the intervention as intended (i.e. receive all appropriate IOP measures, eye drops, and follow-up visits) 3.5 The number / proportion of participants who do not receive each component of the intervention 3.6 The proportion of participants who do not attend the four-week follow-up visit 3.7 The average (and some measure of variance) time taken to complete the initial visit: 3.7.1 For first-line (initial) responders 3.7.2 For second-line (initial) responders 3.7.3 For others 3.8 The proportion of participants that initiate eye drop therapy 3.9 The proportion of participants who instil eye drops as prescribed (and how this changes over the four-week period between initial and follow-up visit) 3.10 The average time interval between eye drop use (and how this changes over the four-week period between initial and follow-up visit) 3.11 The proportion of participants who discontinue eye drop therapy during this time period and time to discontinuation 3.12 The average (and measure of variance) time taken to complete the follow-up visit 3.13 The average (and measure of variance) in IOP at: 3.13.1 Baseline (prior to commencing eye drop treatments) 3.13.2 Following first-line eye drops being instilled 3.13.3 Following instilling final eye drop treatment at initial visit 3.13.4 At four weeks In responders who adhered adequately In responders who did not adhere adequately In non-responders | — |
Secondary
| Measure | Time frame |
|---|---|
| RQ1: 1.1 Qualitative analysis (using framework analysis, FA) of a sample of consultations between patients and healthcare professionals (HCPs) to answer 'what is the usual care for patients?' 1.2 Quantitative analysis of survey designed to determine the extent to which models of care identified in (1.1) are used in Wales. RQ2: 2.1 Qualitative analysis of focus-group and stakeholder interviews RQ4: 4.1 Qualitative analysis (using framework analysis, FA) of interviews with patients and HCPs to answer ‘Is the CMGC acceptable to patients and HCPs?’ RQ5: We will evaluate the study findings against the following criteria for progression to a pilot RCT of the CMGC: 5.1 40% of patients approached are recruited to the study 5.2 50% of patients receive the intervention as intended 5.3 60% of eligible patients recruited over 6 months | — |
Countries
United Kingdom
Contacts
Public ContactSimon Read
Outcome results
None listed